Thursday, May 23, 2013

Many
Americans take dietary supplements with the intention of meeting their
nutritional needs, as well as to improve or maintain their overall health.
These consumers want accurate information on the effectiveness and proper
use of dietary supplements and access to the dietary supplements of their
choice. The federal government has an interest in ensuring that the supplements Americans
consume are high quality, free from contaminants, and accurately labeled.
Because dietary supplements are intended to supplement the diet, their
processing and manufacture are regulated by the U.S. Food and Drug
Administration (FDA) in a manner similar to food, with some differences
that will be outlined in this report. The Federal Trade Commission (FTC), in coordination
with the FDA, regulates dietary supplement advertising.

In contrast with the authority under which drugs and medical devices are
regulated, dietary supplements are regulated as food under the Federal
Food, Drug, and Cosmetic Act (FFDCA), and the FDA does not take regulatory
action on food or dietary supplements until something goes wrong with a
product that is on the market. The FDA has the authority to take action
regarding supplements that are labeled incorrectly (misbranded) or contain
unsafe ingredients (adulterated). The FDA is made aware of potential
misbranding or adulteration through inspections, adverse event reports,
and citizen petitions.

Consumers, the health care and dietary supplement industries, Congress, and
federal regulators all have a stake in supplement identification,
effectiveness, and safety. Current federal policy toward regulating
dietary supplements was intended to balance these competing interests. DSHEA provided
FDA the authority to take action against products that were unsafe or
adulterated, but emphasized that FDA should not take actions that would
impose unreasonable regulatory barriers limiting or slowing the flow of
safe products and accurate information to consumers. As the supplement
market has grown and diversified, the regulatory and research questions have
become more complex. This report discusses current areas of regulatory and
legislative concern, including the identification of products as dietary
supplements, their role in individuals’ health and health care, and recent
issues regarding supplement safety.

Date of Report: May 6, 2013
Number of Pages: 29Order Number: R43062Price: $29.95

For email and phone orders, provide a Visa, MasterCard, American Express, or Discover card
number, expiration date, and name on the card. Indicate whether you want e-mail
or postal delivery. Phone orders are preferred and receive priority processing.